A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Interferon alfa-2a (Drug); Zidovudine (Drug); Zalcitabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Fischl MA, Study Chair
Richman DD, Study Chair
Summary
To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in
combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with
HIV infection and CD4 count < 400 cells/mm3.
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN
alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites
of viral replication may improve HIV inhibition and produce more effective and sustained
anti-HIV effects.
Clinical Details
Official title: A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3
Study design: Treatment, Safety Study
Detailed description:
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN
alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites
of viral replication may improve HIV inhibition and produce more effective and sustained
anti-HIV effects.
Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or
combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after
enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks
thereafter. Mean duration of follow-up is expected to be 13 months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day
pyridoxine).
- Phenytoin for < grade 2 peripheral neuropathy.
- A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe
Pneumocystis carinii pneumonia (PCP).
- Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir
daily), and Mycobacterium tuberculosis.
Patients must have:
- HIV infection.
- CD4 count < 400 cells/mm3 within 30 days prior to study entry.
NOTE:
- Minimal Kaposi's sarcoma is allowed.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Active opportunistic infection requiring acute therapy.
- Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis,
or mycobacterial infection.
- Malignancy (other than minimal Kaposi's sarcoma) requiring therapy.
- Grade 2 or worse peripheral neuropathy.
Concurrent Medication:
Excluded:
- Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or
investigational drugs (unless approved by the protocol chairs).
- Recombinant erythropoietin, G-CSF, or GM-CSF.
- Drugs that cause peripheral neuropathy, e. g., gold, hydralazine, nitrofurantoin,
vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the
protocol chairs).
Concurrent Treatment:
Excluded:
- Radiation therapy (unless approved by the protocol chairs).
Patients with the following prior conditions are excluded:
- History of intolerance to AZT at 600 mg/day or less.
- Unexplained temperature of 38. 5 degrees C persisting for 14 days or longer.
- Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14
days or longer.
Prior Medication:
Excluded:
- Acute therapy for opportunistic infection within 14 days prior to study entry.
- Prior ddC, ddI, or IFN alfa-2a.
Active substance abuse.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Zalcitabine Click here for more information about Interferon alfa-2a
Related publications: Fischl MA, Richman DD, Saag M, Meng TC, Squires KE, Holden-Wiltse J, Meehan PM. Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-alpha2a in patients with HIV. AIDS Clinical Trials Group Study 197. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 1;16(4):247-53.
Last updated: June 23, 2005
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